laboratories shall be operated in conformance with the California Business and
Professions Code, Division 2, Chapter 3 (Sections 1200 to 1322, inclusive) and
the California Administrative Code, Title 17, Chapter 2, Subchapter 1, Group 2
(Sections 1030 to 1057, inclusive).
(b) All hospitals shall maintain clinical
laboratory services and equipment for routine laboratory work, such as
urinalysis, complete blood counts, blood typing, cross matching and such other
tests as are required by these regulations.
(c) All hospitals shall maintain or make
provision for clinical laboratory services for performance of tests in
chemistry, microbiology, serology, hematology, pathology and such other tests
as are required by these regulations.
(d) Written policies and procedures shall be
developed and maintained by the person responsible for the service in
consultation with other appropriate health professionals and administration.
Policies shall be approved by the governing body. Procedures shall be approved
by the administration and medical staff where such is appropriate.
(e) The responsibility and the accountability
of the clinical laboratory service to the medical staff and administration
shall be defined.
of the clinical laboratory shall assure that:
(1) Examinations are performed accurately and
in a timely fashion.
are established governing the provision of laboratory services for
(3) Laboratory systems
identify the patient, test requested, date and time the specimen was obtained,
the time the request reached the laboratory, the time the laboratory completed
the test and any special handling which was required.
(4) Procedures are established to ensure the
satisfactory collection of specimens.
(5) A communications system to provide
efficient information exchange between the laboratory and related areas of the
hospital is established.
quality control system within the laboratory designed to ensure medical
reliability of laboratory data is established. The results of control tests
shall be readily available in the hospital.
(7) Reports of all laboratory examinations
are made a part of the patient's medical record as soon as is
(8) No laboratory
procedures are performed except on the order of a person lawfully authorized to
give such an order.
Tissue specimens shall be examined by a physician who is certified or eligible
for certification in anatomical and/or clinical pathology by the American Board
of Pathology or possesses qualifications which are equivalent to those required
for certification. Oral specimens may be examined by a dentist who is certified
or eligible for certification as an oral pathologist by the American Board of
Oral Pathology. A record of his findings shall become a part of the patient's
(1) A tissue file shall be
maintained at the hospital or the principal office of the consulting
use, storage and disposal of radioactive materials shall comply with the
California Radiation Control Regulations, Subchapter 4, Chapter 5, Title 17,
California Administrative Code.
Where the hospital depends on outside blood banks, there shall be a written
agreement governing the procurement, transfer and availability of
(j) Periodically, an
appropriate committee of the medical staff shall evaluate the services provided
and make appropriate recommendations to the executive committee of the medical
staff and administration.